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Amcor

Invests in packaging tech and sustainability

Quality & Technical Manager - Manufacturing

Validation, Compliance & Quality SystemsUpdated on Nov 12
Full-timeCalifornia, USAIn-person

About the Job

Requirements

  • A minimum of 10 years of manufacturing industry experience, including positions in both quality assurance/quality control and Operations/Production.
  • Seven years of experience or involvement in Technical and Quality Management with medical device experience.
  • Two to three years of demonstrated achievement in a leadership or supervisory position.
  • Demonstrated project management experience.
  • Knowledge of Quality System Software and Quality Engineering tools.
  • A thorough understanding of GMP 21 CFR Part 820, FDA requirements, ISO 13485 and medical validation experience, and common Quality and Problem Solving tools such as Statistical Analysis, DOE, Pareto charts and Histograms.
  • Strong proficiency in PC-based tools including Excel, PowerPoint, Word and Outlook.
  • Bilingual English/Spanish speaking ability.
  • Effective communication skills to execute quality programs and communicate with employees at all levels of the plant.
  • Exceptional problem-solving and analytical skills, with the ability to make quick and appropriate decisions.
  • Ability to collaborate and influence, and a strong customer service focus.
  • Strong team leadership ability to manage, coach, and develop people, talent and skills.
  • ASQ CMQ/QE or ASQ CQE certification is preferred.
  • Previous SAP experience is a plus.

Responsibilities

  • Act as a safety leader and put safety first in all responsibilities; work with the EHS Manager to establish and maintain policies and programs that assure a safe working environment.
  • Provide hands-on management of the elements of the Quality Management System, including quality action plans, validations, customer complaints and internal holds, standard work, audit processes, document control, test methods, and quality test equipment; ensure training is conducted for Quality Management System elements.
  • Ensure plant systems are tied into corporate standards via reviews and audits.
  • Generate scorecards and reports for all aspects of plant quality, including VOC, CARs, SCARs, COAs, SPC reporting, losses, and internal, third-party, and customer audits.
  • Ensure quality systems meet customer specifications, internal requirements, and applicable regulatory requirements, including ISO 13485, GMP 21 CFR Part 820, FDA, medical, and pharmaceutical requirements.
  • Conduct advanced statistical analysis and process capability analysis for process and product quality.
  • Independently manage customer interactions relating to product or service quality.
  • Identify, define, and promote awareness of customer requirements for the plant.
  • Manage and train the activities of the Quality Team, including lab and quality technicians.
  • Perform supervision of direct reports, including performance reviews, hiring, salary administration, training, recognition, and discipline.
  • Direct activities and priorities of Process Engineers and the Quality Department.
  • Identify, develop, and implement plans for cost reduction, waste reduction, increased throughput, and general process improvement.
  • Ensure compliance and monitor resources for maintenance and continuous improvement of the plant Product Quality Safety systems.
  • Assist in Product Development by applying manufacturing capabilities knowledge to ensure design control and scale-up protocol are met at project initiation.
  • Administer incoming orders, specifications, waivers, and projects in the Amcor Commercialization System; administer the product specification system, creating new specifications with Sales and R&D and requesting revisions or deviations as required to optimize performance.
  • Supervise internal validations to determine key process variables for manufacturing processes.
  • Take the necessary actions to ensure new products conform to customers’ manufacturing and quality needs and fall within manufacturing process capabilities.
  • Maintain the facility’s overall Quality system and department by ensuring procedures and practices are appropriate to comply with customer requirements and specifications; oversee incoming verification of purchased products, in-process inspection, and final product review.
  • Demonstrate proactive awareness of and adherence to relevant Environmental, Health and Safety policies and procedures.
  • Act as a liaison between Sales, R&D, Manufacturing, and customers regarding quality expectations, performance at customer facilities, and manufacturing process capabilities, keeping parties informed and updated.
  • Manage the Corrective Action system by assisting Supply Chain, Customer Service, Customer Focused Quality, and manufacturing groups in resolving quality concerns and complaints.
  • Actively participate in and lead teams supporting continuous improvement initiatives and establish a continuous improvement culture.
  • Establish a culture of continuous improvement in Quality.
  • Serve as an active member of the plant leadership team.

Desired Qualifications

  • ASQ CMQ/QE or ASQ CQE certification.
  • Previous SAP experience.

About the Company

Amcor

Invests in packaging tech and sustainability

Amcor Corporate Venturing invests in early-stage and growth-stage packaging startups to advance sustainable packaging, new business models, and digitization across the packaging value chain. The fund provides more than capital by connecting portfolio companies to Amcor’s global network, technical resources, and market knowledge to help technologies scale. Its approach combines funding with strategic collaboration to address challenges like recyclability and waste reduction, aligning with Amcor’s broader sustainability and innovation goals. The main aim is to accelerate innovation in packaging and circular economy initiatives, leveraging Amcor’s reach to bring new solutions to market.

Company size
10,001+
Company stage
IPO
Headquarters
Zurich, Switzerland
Founded
1864

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